Manufacturer

Oehm und Rehbein

GermanyLegal entities : Oehm und Rehbein GmbH

Markets : Germany · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 5 · class II · latest in 2018 · see on the FDA website

Public contracts won : Germany 1

6 categories, 19 models including 19 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Mobile radiographic units	Z11039016	Amadeo M-DR mini2 refs Leonardo DR Go Leonardo DR mini II Leonardo DR mini III Leonardo DR nano 1 other Leonardo DR pico	IIb MDR	EUDAMED record Report an error
X-ray tube assembly	Z11039012	Amadeo C-DR 200 Amadeo C-DR system3 refs Amadeo R-AX motorized Amadeo R motorised3 refs Amadeo R-DR2 refs Amadeo S-AX motorised Amadeo S motorised3 refs Amadeo T-DR system2 refs 1 other Amadeo Z-AX motorised Amadeo Z motorised3 refs	IIb MDR	EUDAMED record Report an error
Systems for direct digital radiology (dr) - software accessories	Z11031182	dicomPACS® dicomPACS®DX-R ORmed	IIa, IIb MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	dicomPACS® MobileView ORCA®	IIa MDR	EUDAMED record Report an error
Radiogenic complexes	Z11039005	Divario CR-T2 Divario CR-T System	IIa MDR	EUDAMED record Report an error
Systems for direct digital radiology (dr) - hardware accessories	Z11031180	Medici DR system	IIa MDR	EUDAMED record Report an error

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